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Last Updated: April 2, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 075417


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NDA 075417 describes CLOZAPINE, which is a drug marketed by Barr Labs Inc, Mylan, Teva Pharms Usa, Accord Hlthcare, Aurobindo Pharma Ltd, Ivax Sub Teva Pharms, Mayne Pharma, Par Pharm, Sandoz, Sun Pharm Inds Inc, and Zydus Pharms, and is included in thirteen NDAs. It is available from ten suppliers. Additional details are available on the CLOZAPINE profile page.

The generic ingredient in CLOZAPINE is clozapine. There are thirteen drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the clozapine profile page.
Summary for 075417
Tradename:CLOZAPINE
Applicant:Mylan
Ingredient:clozapine
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 075417
Medical Subject Heading (MeSH) Categories for 075417
Suppliers and Packaging for NDA: 075417
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CLOZAPINE clozapine TABLET;ORAL 075417 ANDA Mylan Pharmaceuticals Inc. 0378-0825 0378-0825-01 100 TABLET in 1 BOTTLE, PLASTIC (0378-0825-01)
CLOZAPINE clozapine TABLET;ORAL 075417 ANDA Mylan Pharmaceuticals Inc. 0378-0860 0378-0860-01 100 TABLET in 1 BOTTLE, PLASTIC (0378-0860-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength25MG
Approval Date:May 27, 1999TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength100MG
Approval Date:May 27, 1999TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength12.5MG
Approval Date:Apr 15, 2010TE:RLD:No

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